Study of ELV001 to Evaluate Safety and Efficacy in Adults With Active Rheumatoid Arthritis Not Responding to Methotrexate and TNF Inhibitors

What this Trial Is About

Researchers are evaluating ELV001, a drug being studied as an add-on therapy for adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of different doses of ELV001. Approximately 180 to 220 participants aged 18 to 75 with active rheumatoid arthritis will be enrolled to better understand the drug's impact on disease activity. The study has four groups: a placebo group and three groups receiving ELV001 at doses of 25 mg, 75 mg, or 125 mg daily. The study includes a 4-week screening period, a 12-week double-blind treatment period where participants receive their assigned treatment, followed by a 12-week treatment extension phase. In the extension, those initially on placebo or 25 mg switch to 75 mg or 125 mg doses. The study concludes with a 4-week safety follow-up. Participants will attend regular visits for assessments including disease activity scores, joint counts, patient questionnaires, vital signs, laboratory tests, ECGs, and blood samples for drug levels. Researchers will monitor side effects and measure changes in disease symptoms up to 32 weeks. The main outcome focuses on the change in disease activity score from baseline to week 12, with additional evaluations through week 24 and safety monitoring continuing through week 28.

A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)